Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)

NCT06467435 | Terminated Phase 1 FDA Drug

• 1 other identifier: 94519
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The study is comprised of two cohorts. Cohort 1 will examine pharmacokinetics of K9 in 3 healthy volunteers over 24 hours. This cohort has been completed. Cohort 2 will involve up to 10 patients with TED. Patients will receive oral K9 BID for up to 24 weeks and will be followed up to a total of 26 weeks with a primary endpoint of safety.

Conditions

Thyroid Eye Disease

Keywords

Kamuvudine-9; K9

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Frequency of participants experiencing ocular or systemic adverse events.

  26 weeks

• plasma concentrations of K9

  plasma concentrations measured after a single oral dose in healthy adults. For each of these time points 5 ml of blood will be drawn.

  Pharmacokinetic samples collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

Secondary Outcomes (8)

• Change in Standardized Patient Evaluation of Eye Dryness (SPEED) symptoms

  Screening (Baseline), and Weeks 4, 14, and 24

• Change in Diplopia

  Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24

• Change in Study Visit in Clinical Activity Score (CAS),

  Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24

• Change in proptosis

  Screening (Baseline), Day 1 Visit, and weeks 4, 14, and 24

• Change in Graves' ophthalmopathy-specific quality-of-life scale (GO-QOL)

  Screening (Baseline) and weeks 4, 14, and 24

Study Arms (2)

Patients with Thyroid Eye Disease (TED)

EXPERIMENTAL

Participants receive a regimen of 96 mg tablets of K9 twice a day for 24 weeks

Drug: Kamuvudine-9

Healthy Volunteers

EXPERIMENTAL

Participants receive one dose of 96 mg tablets of K9 based on weight

Drug: Kamuvudine-9

Interventions

Kamuvudine-9 DRUG

96 mg tablets taken twice a day for 24 weeks

Also known as: K9

Patients with Thyroid Eye Disease (TED)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1
• Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol
• Cohort 2
• Diagnosed with Thyroid Eye Disease (TED).
• Symptomatic TED diagnosed no more than 9 months earlier.
• Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye.
• Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.

You may not qualify if:

• Cohort 1
• Body weight less than 55 kg.
• Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
• Cohort 2
• Body weight less than 55 kg.
• Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
• Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit.
• History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery.
• History (last 6 weeks) of use of systemic immunosuppressants (e.g. mycophenolate), intravenous immunoglobulin, or plasmapheresis.
• Clinical activity score \< 3
• Uncontrolled diabetes or hypertension
• History of mental / psychiatric disorder

Sponsors & Collaborators

• Peter Timoney: lead
• Inflammasome Therapeutics: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Timoney

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: November 6, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)